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510(k) Data Aggregation
K Number
K123699Device Name
FAHL TRACHEOSTOMY TUBES (MULTIPLE)
Manufacturer
ANDREAS FAHL MEDIZINTECHNIK-VERTRIEB GMBH
Date Cleared
2013-08-12
(252 days)
Product Code
JOH, BTO, BTR
Regulation Number
868.5800Why did this record match?
Applicant Name (Manufacturer) :
ANDREAS FAHL MEDIZINTECHNIK-VERTRIEB GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fahl Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.
Device Description
The Fahl Tracheostomy Tubes (Duravent, Duracuff, Laryngotec, Duratwix, Silvervent, Spiraflex, and Tracheotec) are available cuffed or uncuffed. They can be obtained sieved or unsieved, with or without speaking valve, cuffed or uncuffed, with or without inner cannulas. The accessories comprise different Humid Moist Exchangers (HME), decannulation plugs, neck holders, and stoma buttons. Fahl offers the tubes in varying sizes and length so that the physician can select a tracheostomy tube, which best fits the individual needs of the patient. All Fahl Tracheostomy Tubes are for adults only and available on prescription.
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